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Clinical Trials/NCT03688620
NCT03688620
Completed
Phase 4

Enhanced Safety Surveillance of GSK's Quadrivalent Seasonal Influenza Vaccines

GlaxoSmithKline1 site in 1 country1,060 target enrollmentOctober 5, 2018
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ConditionsInfluenza, Human

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Influenza, Human
Sponsor
GlaxoSmithKline
Enrollment
1060
Locations
1
Primary Endpoint
Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The purpose of this study is to comply with the European Medicines Agency (EMA) guidance on enhanced safety surveillance for seasonal influenza vaccines in the European Union (EU) and aims to assess adverse events of interest (AEIs) experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine (AlphaRix Tetra in Belgium; Influsplit Tetra in Germany, Fluarix Tetra in Spain).

This study may help to inform decisions regarding future influenza vaccine safety surveillance for influenza vaccines in Europe.

Detailed Description

The key objective of the EMA enhanced safety surveillance is to rapidly detect a significant increase in the frequency and/or severity of expected reactions (local, systemic or allergic reactions) that may indicate a potential risk. The study is a passive enhanced safety surveillance aiming to collect prospectively AEIs and/or other AEs experienced within 7 days post vaccination with GSK's quadrivalent seasonal influenza vaccine, using customized Adverse Drug Reaction cards. Data will be collected via the healthcare provide (HCP) or study medical staff who administer the seasonal influenza vaccination or who provide the inform consent form and the ADR cards.

Registry
clinicaltrials.gov
Start Date
October 5, 2018
End Date
January 4, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., complete the ADR card, return for the next scheduled visit or return the ADR card by mail within a timely manner).
  • •A male or female subject vaccinated with GSK's quadrivalent seasonal influenza vaccine (one or two dose schedule) according to the routine medical practices between 01 October 2018 and 31 December
  • •Subjects aged 6 months or above at the time of the vaccination according to the countries' specificities.
  • •Written informed consent/informed assent obtained from the subjects/subjects' parent(s)/Legally Acceptable Representative(s) (LARs).

Exclusion Criteria

  • •Child in care.

Outcomes

Primary Outcomes

Cumulative Percentage of Subjects Reporting Any Adverse Events of Interest (AEIs) and/or Adverse Events (AEs) Using Adverse Drug Reaction (ADR) Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between Intenational Organization for Standardization (ISO) weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards.

Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.

Cumulative Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.

Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA Preferred Term [PT], Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

Cumulative Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were diarrhoea, nausea, and vomiting.

Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

Cumulative Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were chills, face oedema, fatigue, injection site erythema, injection site pain, injection site swelling, and pyrexia.

Cumulative Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were anaphylactic reaction and hypersensitivity.

Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

Cumulative Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were conjunctivitis and rhinitis.

Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1, by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was decreased appetite.

Cumulative Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was decreased appetite.

Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

Cumulative Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were arthropathy and myalgia.

Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

Cumulative Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were febrile convulsion and headache.

Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEI listed on the ADR card was irritability.

Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

Cumulative Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. The pre-defined AEI listed on the ADR card was irritability.

Cumulative Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were cough, dysphonia, epistaxis, nasal congestion, oropharyngeal pain, rhinorrhoea, and wheezing.

Cumulative Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. The pre-defined AEIs listed on the ADR card were rash and rash generalised.

Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for cardiac disorders.

Cumulative Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for cardiac disorders.

Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

Cumulative Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for ear and labyrinth disorders.

Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for investigations.

Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for eye disorders.

Cumulative Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for eye disorders.

Cumulative Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for injury, poisoning and procedural complications.

Cumulative Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52.There were no predefined AEIs listed on the ADR card for investigations.

Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall

Time Frame: Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a first dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 1 vaccination (i.e., week 40) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 40 and 52. No vaccination (Dose 1) was administered from ISO week 49 onwards. There were no predefined AEIs listed on the ADR card for vascular disorders.

Cumulative Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group

Time Frame: Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days

The cumulative percentage of subjects was calculated as follows (per 100 subjects): the denominator was the number of subjects vaccinated with a second dose of the GSK's quadrivalent seasonal influenza vaccine at any point from dose 2 vaccination (i.e., week 46 for the second dose) up to the end of the week of interest; the numerator was the number of subjects among those vaccinated subjects, who reported the AE at least once on the ADR card within 7 days following vaccination. Vaccination period was defined between ISO weeks 46 and 52. There were no predefined AEIs listed on the ADR card for vascular disorders.

Secondary Outcomes

  • Weekly Percentage of Subjects Reporting Any AEIs and/or Other Aes, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any AEIs and/or AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Gastrointestinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Immune System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Infections and Infestations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Metabolism and Nutrition Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Musculoskeletal and Connective Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Nervous System Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Psychiatric Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Respiratory, Thoracic and Mediastinal Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Eye Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Skin and Subcutaneous Tissue Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Cardiac Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Ear and Labyrinth Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Injury, Poisoning and Procedural Complications by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Gastrointestinal Disorders (MedDRA Primary System Organ Class [SOC]), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Investigations by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 1 by Vaccine Group and Overall(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Vascular Disorders by MedDRA PT, Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1, by Vaccine Group and Overall, and by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Age Category(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any AEs, Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Gastrointestinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Weekly Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any AEs Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any General Disorders and Administration Site Conditions (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Immune System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Metabolism and Nutrition Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Infections and Infestations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Musculoskeletal and Connective Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Nervous System Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Psychiatric Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Respiratory, Thoracic and Mediastinal Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Skin and Subcutaneous Tissue Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Cardiac Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Ear and Labyrinth Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Eye Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Injury, Poisoning and Procedural Complications (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 1 by Vaccine Group and Overall, by Risk Status(Within 7 days post Dose 1 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Vascular Disorders (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)
  • Cumulative Percentage of Subjects Reporting Any Investigations (MedDRA Primary SOC), Using ADR Card, Post Dose 2 in the Vaccinated_Fluarix Tetra Group, by Risk Status(Within 7 days post Dose 2 i.e. the day of vaccination and the following 6 days)

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Not Applicable
Enhanced safety surveillance of GSK’s quadrivalent seasonal influenza vaccines in Belgium, Germany and Spain during the 2020/21 influenza seasoJ10Influenza due to identified seasonal influenza virus
DRKS00023084GlaxoSmithKline Biologicals SA1,055
Completed
Not Applicable
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in KoreaNeoplasms, Rectal
NCT03671369GlaxoSmithKline670
Unknown
Not Applicable
Safety Study of GlaxoSmithKline (GSK) Biologicals' Human Papillomavirus (HPV) Vaccine in Healthy Vietnamese Women According to a 0, 1, 6 Month ScheduleHuman Papillomavirus (HPV) Vaccine
NCT00572000National Institute for Control of Vaccine and Biologicals222
Completed
Not Applicable
Passive Enhanced Safety Surveillance of Stamaril® Vaccine in KoreaYellow Fever
NCT03541694Sanofi Pasteur, a Sanofi Company622
Unknown
Not Applicable
e-Pharmacovigilance II - Surveillance for Safety and Effectiveness - Calling for Earlier Detection of Adverse ReactionsDiabetesDepressionInsomniaHypertension
NCT02087293Brigham and Women's Hospital38,400